AstraZeneca Wins European Approval for Lung Cancer Drug Tagrisso

AstraZeneca Wins European Approval for Lung Cancer Drug Tagrisso

AstraZeneca on Wednesday said European regulators have approved a potential blockbuster lung cancer drug that the company hopes will form a key plank of its growth plans.

The company believes the drug, called Tagrisso, could generate as much as $3 billion a year in sales, potentially helping it achieve its ambition to increase overall revenue to $45 billion by 2023, compared with about $26 billion in 2014. However, analysts have been more cautious about the drug’s potential, with Citi’s Andrew Baum forecasting sales of $1 billion by 2020.

Tagrisso is the first drug to target a subset of patients whose tumors have spread and developed a normally treatment-resistant mutation called T790M.

AstraZeneca said Tagrisso was the first new drug to win accelerated approval by the European Medicines Agency. The decision comes two months after Tagrisso was given the green light by the U.S. Food and Drug Administration.

The drug entered its first human trial in 2013, and has sped through development. It was submitted to regulators based on the results of two “phase two,” or mid-stage studies, on a total of 474 patients. Those studies showed the drug shrunk tumors in 66% of cases.

Normally, companies must run larger so-called phase-three trials before they can submit a drug to regulators. AstraZeneca is also running a continuing phase-three clinical trials on Tagrisso to gather more data on the drug’s safety and effectiveness.

Lung cancer is one of the deadliest forms of the disease. Nearly 354,000 people in Europe died from lung cancer in 2012, according to Cancer Research UK, a research charity. The majority of patients have a form of the disease known as non-small cell lung cancer, of which around 10% develop a mutation in a gene known as EGFR. Of those patients, around two-thirds go on to develop the T790M mutation during treatment.

Sean Bohen, head of medicines development at AstraZeneca, said the fast approval “reflects the importance of this innovative medicine for addressing the needs of patients with lung cancer who have the T790M mutation.”